RecruitingPhase 4NCT07474519

Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer

An Assessment of Patient Position and Intravesical BCG Dwell Time


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase IV trial studies whether there is a relationship between how a patient is positioned while receiving bacillus Calmette Guerin (BCG) within the bladder (intravesical) and how long BCG stays in the bladder (dwell time) to improve the treatment of non-muscle invasive bladder cancer. For the past 40 years, intravesical BCG has been used for the treatment of non-muscle invasive bladder cancer. An important factor for BCG treatment is the dwell time, which is the period of time a patient can hold the BCG medication in the bladder after it has been given. Normally, patients are instructed during intravesical BCG treatment to avoid emptying the bladder for 2 hours after the BCG is given. However, this may be difficult for some patients who may have limited bladder capacity, restricted movement, or severe urinary symptoms. There have been studies outlining the relationship with increased dwell time and how well the treatment works, but studies on the potential impact of patient positioning or activity on the patient's ability to retain the drug are limited. Researchers hope by studying whether there is a relationship between patient positioning during intravesical BCG treatment and dwell time, they may be able to improve how BCG treatment for non-muscle invasive bladder cancer is given, especially for patients with limited bladder capacity, restricted movement, or severe urinary symptoms.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how different body positions (lying down versus sitting up) during BCG treatment — a standard immune therapy delivered directly into the bladder for early-stage bladder cancer — affect how well the treatment works. Participants will also wear a fitness tracker to monitor movement during the treatment period. **You may be eligible if...** - You have intermediate or high-risk non-muscle-invasive bladder cancer (early-stage bladder cancer) - You are starting your first course of BCG treatment (not yet begun) - You can comfortably lie flat and sit upright for up to 2 hours each - You are willing to wear a fitness tracker for at least 5 days during the study - You are able to participate in remote video or phone check-ins **You may NOT be eligible if...** - You have received BCG treatment within the past year - You are known to be unable to hold the BCG fluid in your bladder - You have significant urinary leakage or urgency (overactive bladder) - You are unwilling to wear the fitness tracker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAccelerometry

Receive and wear Fitbit

BIOLOGICALBCG Solution

Given intravesically with no activity restrictions

BIOLOGICALBCG Solution

Given intravesically in lying down position

BIOLOGICALBCG Solution

Given intravesically in sitting position

OTHERElectronic Health Record Review

Ancillary studies

BEHAVIORALPatient Discharge

Receive immediate clinic discharge

OTHERSurvey Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07474519


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